Novosept Forte

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Novosept Forte uses

Novosept Forte consists of Cetylpyridinium Chloride, Tetracaine Hydrochloride, Zinc Sulfate.

Cetylpyridinium Chloride:


Drug Facts

Active Ingredient: PEROX-A-MINT: Purpose
Hydrogen Peroxide 1.5% Oral Debriding Agent
Active Ingredient: ANTIPLAQUE*: Purpose
Novosept Forte (Cetylpyridinium Chloride) chloride.05% Antigingivitis/antiplaque

USES

Suction Swab with Perox-A-Mint:

Aids in the removal of secretions and debris.

Suction Toothbrush with Antiplaque Solution:

Aids in the removal and prevention of plaque that leads to gingivitis.

Oropharyngeal Suction Catheter:

Aids in the removal of secretions from the oropharyngeal cavity only.

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WARNINGS

Suction Swab with Perox-A-Mint Solution:

  • Sore mouth symptoms do not improve in 7 days.
  • Swelling, rash or fever develops.
  • Irritation, pain or redness persists or worsens.
Suction Toothbrush with Antiplaque Solution:

  • Gingivitis, bleeding or redness persists for more than 2 weeks.
  • You have painful or swollen gums, pus from the gum line, loose teeth or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
Suction Swab with Perox-A-Mint Solution:

Keep out of reach of children.

If more than used for debriding is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Suction Toothbrush with Antiplaque Solution:

Keep out of reach of children under 6 years of age

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Suction Swab with Perox-A-Mint Solution:

  • Before opening, turn package over, burst solution packet with thumbs.
  • Peel lid to open.
  • Remove Mouth Moisturizer and Applicator Swab.
  • Attach Suction Swab to Suction Handle.
  • Clean teeth and oral cavity for approximately one minute.
  • To suction, slide switch to ON. When finished, return switch to OFF.
  • To clear tubing, rinse with sterile saline or appropriate solution.
  • Discard Suction Swab. Reattach Covered Yankauer to Suction Handle.
  • Place Mouth Moisturizer on Applicator Swab.
  • Apply as needed to lips and inside mouth.
  • Use up to 4 times daily or as directed by a dentist or doctor.
  • Children under 12 years of age: supervise use.
  • Children under 3 years of age: consult a dentist or doctor.
  • Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.
  • Ensure foam is intact after use. If not, remove any particles from oral cavity.

Suction Toothbrush with Antiplaque Solution:

  • Before opening, turn package over, burst solution packet with thumbs.
  • Peel lid to open.
  • Remove Mouth Moisturizer and Applicator Swab.
  • Attach Toothbrush to Suction Handle.
  • Clean teeth and oral cavity for approximately one minute.
  • To suction, slide switch to ON. When finished, return switch to OFF.
  • To clear tubing, rinse with sterile saline or appropriate solution.
  • Discard Toothbrush. Reattach Covered Yankauer to Suction Handle.
  • Place Mouth Moisturizer on Applicator Swab.
  • Apply as needed to lips and inside mouth.
  • Adults and children 12 years of age and older: use two times daily or as directed by a dentist. Do not swallow the solution.
  • Children ages 6 to 12 years: supervise use.
  • Children under 6 years of age: do not use.
  • Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.
  • Ensure foam is intact after use. If not, remove any particles from oral cavity.

Oropharyngeal Suction Catheter:

  • Peel lid to open.
  • Attach Suction Cather to Suction Handle.
  • Suction secretions from the oropharyngeal cavity.
  • To suction, slide switch to ON. When finished, return switch to OFF.
  • To clear tubing, rinse with sterile saline or appropriate solution.
  • Discard Suction Catheter. Reattach Covered Yankauer to Suction Handle.
  • Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.

Caution

  • Federal (U.S.A.) law restricts this device to sale by or on the order of a physician or licensed practicioner.
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Inactive Ingredients

Suction Swab with Perox-A-Mint Solution:

Water, menthol flavor, polysorbate 80, phosphoric acid, sodium saccharin, Blue 1 (CI 42090), Yellow 6 (CI 15985)

Suction Toothbrush with Antiplaque Solution:

Water, sorbitol, peppermint flavor, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, Blue 1 (CI42090)

Questions?

Call toll-free 800–323–2220

Manufactured for Sage Products LLC Cary, IL

NOT MADE WITH NATURAL RUBBER LATEX. FOR SINGLE USE ONLY. MADE IN U.S.A.

Novosept Forte

QCare 6804 QCare Film 6804 QCare Drug Facts 6804

QCare Oral Cleansing and Suctioning System, Q8

QCare 6808 QCare film 6808 QCare Drug Facts 6808

Antiplaque Solution, Perox-A-Mint

Antiplaque Solution Perox-A-Mint

Tetracaine Hydrochloride:


1 INDICATIONS AND USAGE

Novosept Forte (Tetracaine Hydrochloride) TM is indicated for regional anesthesia when performing a restorative procedure on Teeth 4-13 and A-J in adults and children who weigh 40 kg or more.

Novosept Forte (Tetracaine Hydrochloride) contains Novosept Forte (Tetracaine Hydrochloride) HCl, an ester local anesthetic, and oxymetazoline HCl, a vasoconstrictor. Novosept Forte (Tetracaine Hydrochloride) is indicated for regional anesthesia when performing a restorative procedure on Teeth 4-13 and A-J in adults and children who weigh 40 kg or more ( 1).

2 DOSAGE AND ADMINISTRATION

Novosept Forte is for intranasal use only ( 2). Administer Novosept Forte (Tetracaine Hydrochloride) ipsilateral (on the same side) to the maxillary tooth on which the dental procedure will be performed.

Age Group Dose
Adults (≥ 18 years old) 2 sprays (0.2 mL per spray),

4 to 5 minutes apart

1 additional spray (0.2 mL) if adequate anesthesia has not been achieved 10 minutes after the second spray
Children who weigh 40 kg or more 2 sprays (0.2 mL per spray),

4 to 5 minutes apart

2.1 Important Dosage and Administration Instructions

  • Novosept Forte (Tetracaine Hydrochloride) is for intranasal use only.
  • Administer ipsilateral (same side) to the maxillary tooth on which the dental procedure will be performed.
  • Wait 10 minutes after administration of Novosept Forte (Tetracaine Hydrochloride) to perform a test drill to confirm that the tooth involved is anesthetized. A patient may not experience the same sensations of numbness or tingling of the lips and cheeks associated with injectable dental anesthetics.

2.2 Dosing in Adults

  • 2 sprays (0.2 mL each) administered 4 to 5 minutes apart in the nostril ipsilateral to the maxillary tooth on which the dental procedure will be performed. Initiate the dental procedure 10 minutes after the second spray.
  • 1 additional spray (0.2 mL) if adequate anesthesia to initiate the dental procedure has not been achieved 10 minutes after the second spray.

2.3 Dosing in Children

  • 2 sprays (0.2 mL each) administered 4 to 5 minutes apart in the nostril ipsilateral to the maxillary tooth on which the dental procedure will be performed. Initiate the dental procedure 10 minutes after the second spray.
Age Group Dose
Adults (≥ 18 years old)
  • 2 sprays (0.2 mL per spray), 4 to 5 minutes apart
  • 1 additional spray (0.2 mL) if adequate anesthesia has not been achieved 10 minutes after the second spray
Children who weigh 40 kg or more
  • 2 sprays (0.2 mL per spray), 4 to 5 minutes apart
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3 DOSAGE FORMS AND STRENGTHS

Novosept Forte (Tetracaine Hydrochloride) Nasal Spray is a pre-filled, single-use, intranasal sprayer containing a clear 0.2 mL aqueous solution at pH 6.0 ± 1.0 comprising 30 mg/mL of Novosept Forte (Tetracaine Hydrochloride) hydrochloride and 0.5 mg/mL of oxymetazoline hydrochloride (equivalent to 26.4 mg/mL Novosept Forte (Tetracaine Hydrochloride) and 0.44 mg/mL oxymetazoline).

Each nasal spray unit delivers one 0.2 mL spray.

Each 0.2 mL spray contains 6 mg Novosept Forte (Tetracaine Hydrochloride) hydrochloride (equivalent to 5.27 mg Novosept Forte (Tetracaine Hydrochloride)) and 0.1 mg oxymetazoline hydrochloride (equivalent to 0.088 mg oxymetazoline).

Nasal spray in pre-filled, single-use sprayer: 6 mg Novosept Forte (Tetracaine Hydrochloride) HCl and 0.1 mg oxymetazoline HCl (equivalent to 5.27 mg Novosept Forte (Tetracaine Hydrochloride) and 0.088 mg oxymetazoline) in each 0.2 mL spray ( 3).

4 CONTRAINDICATIONS

Novosept Forte (Tetracaine Hydrochloride) is contraindicated in patients with a history of allergy to or intolerance of Novosept Forte (Tetracaine Hydrochloride), benzyl alcohol, other ester local anesthetics, p-aminobenzoic acid (PABA), oxymetazoline, or any other component of the product .

Known hypersensitivity to Novosept Forte (Tetracaine Hydrochloride), benzyl alcohol, other ester local anesthetics, p-aminobenzoic acid (PABA), oxymetazoline, or any other component of the product ( 4).

5 WARNINGS AND PRECAUTIONS

Hypertension and Thyroid Disease: Shown to increase blood pressure in some clinical trial patients. Monitor blood pressure. Use in patients with inadequately controlled hypertension or active thyroid disease is not advised.

Epistaxis: Use is not recommended in patients with a history of frequent nose bleeds (≥5 per month). If a decision to use is made, monitor these patients carefully ( 5.2).

Dysphagia: Carefully monitor patients for dysphagia ( 5.3).

Methemoglobinemia: May cause methemoglobinemia, particularly when used with methemoglobin-inducing agents. Use in patients with history of congenital or idiopathic methemoglobinemia not advised. If central cyanosis unresponsive to oxygen therapy occurs, suspect methemoglobinemia, confirm diagnosis with CO-oximetry, and treat with a standard clinical regimen ( 5.4).

Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs ( 5.5).

5.1 Risk of Hypertension

Novosept Forte (Tetracaine Hydrochloride) has not been studied in Phase 3 trials in adult dental patients with blood pressure greater than 150/100 or in those with inadequately controlled active thyroid disease. Novosept Forte (Tetracaine Hydrochloride) has been shown to increase blood pressure in some patients in clinical trials. Monitor patients for increased blood pressure. Use in patients with uncontrolled hypertension or inadequately controlled active thyroid disease of any type is not advised .

5.2 Epistaxis

In clinical trials, epistaxis occurred more frequently with Novosept Forte than placebo. Either do not use Novosept Forte (Tetracaine Hydrochloride) in patients with a history of frequent nose bleeds (≥ 5 per month) or monitor patients with frequent nose bleeds more carefully if Novosept Forte (Tetracaine Hydrochloride) is used. [see Adverse Reactions ( 6.1 )].

5.3 Dysphagia

In clinical trials, dysphagia occurred more frequently with Novosept Forte (Tetracaine Hydrochloride) than placebo. Carefully monitor patients for this adverse reaction.

5.4 Methemoglobinemia

Novosept Forte may cause methemoglobinemia, particularly in conjunction with methemoglobin-inducing agents. Based on the literature, patients with glucose-6-phosphate dehydrogenase deficiency or congenital or idiopathic methemoglobinemia are more susceptible to drug-induced methemoglobinemia. Use of Novosept Forte (Tetracaine Hydrochloride) in patients with a history of congenital or idiopathic methemoglobinemia is not advised.

Patients taking concomitant drugs associated with drug-induced methemoglobinemia, such as sulfonamides, acetaminophen, acetanilide, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, p-aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, and quinine, may be at greater risk for developing methemoglobinemia.

Initial signs and symptoms of methemoglobinemia (which may be delayed for up to several hours following exposure) are characterized by a slate grey cyanosis seen in, e.g., buccal mucous membranes, lips and nail beds. In severe cases, symptoms may include central cyanosis, headache, lethargy, dizziness, fatigue, syncope, dyspnea, CNS depression, seizures, dysrythmia and shock. Methemoglobinemia should be considered if central cyanosis unresponsive to oxygen therapy occurs, especially if methemoglobinemia-inducing agents have been used. Calculated oxygen saturation and pulse oximetry are inaccurate in the identification of methemoglobinemia. Confirm diagnosis by measuring methemoglobin level with co-oximetry. Normally, methemoglobinemia levels are <1%, and cyanosis may not be evident until a level of at least 10% is present.

Treat clinically significant symptoms of methemoglobinemia with a standard clinical regimen such as a slow intravenous infusion of methylene blue at a dosage of 1-2 mg/kg given over a 5 minute period.

5.5 Anaphylactic Reactions

Allergic or anaphylactic reactions have been associated with Novosept Forte (Tetracaine Hydrochloride), and may occur with other components of Novosept Forte (Tetracaine Hydrochloride). They are characterized by urticaria, angioedema, bronchospasm, and shock. If an allergic reaction occurs, seek emergency help immediately.

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6 ADVERSE REACTIONS

The following adverse reactions are described elsewhere in the labeling:

  • Hypertension
  • Epistaxis
  • Dysphagia
  • Methemoglobinemia
  • Anaphylatic Reactions

The most common adverse reactions occurring in >10% of patients include rhinorrhea, nasal congestion, nasal discomfort, oropharyngeal pain, and lacrimation increased ( 6).

Transient, asymptomatic elevations in systolic blood pressure (≥ 25 mm Hg from baseline) and diastolic blood pressures (≥ 15 mm Hg from baseline) have been reported ( 6).

To report SUSPECTED ADVERSE REACTIONS, contact St. Renatus, LLC at 800-865-4925 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The adverse reactions information described below is from Phase 3 randomized, controlled clinical trials [see Clinical Studies ( 14)] . These data reflect exposure to Novosept Forte (Tetracaine Hydrochloride) in 154 adult dental patients and 20 pediatric dental patients (aged 7 to 17 years) with a need for an operative restorative dental procedure requiring local anesthesia for a single vital maxillary tooth (other than a maxillary first, second, or third molar) with no evidence of pulpal pathology. .

Common Adverse Reactions in Adult Dental Patients and Pediatric Patients Weighing 40 kg or More

The most common adverse reactions to occur in Phase 3 trials with Novosept Forte (Tetracaine Hydrochloride) in adult dental patients and pediatric dental patients weighing 40 kg or more were rhinorrhea, nasal congestion, nasal discomfort, oropharyngeal pain, and lacrimation increased [ Table 1] .

No serious adverse events with Novosept Forte (Tetracaine Hydrochloride) have occurred .

SOC / Preferred Term Novosept Forte (Tetracaine Hydrochloride) (N=174) Active Comparator* (N=54) Placebo (N=88)
Respiratory System Disorders 141 (81%) 50 (93%) 18 (21%)
Rhinorrhea (runny nose) 91 (52%) 20 (37%) 3 (3%)
Nasal congestion 56 (32%) 34 (63%) 6 (7%)
Nasal discomfort 45 (26%) 7 (13%) 5 (6%)
Oropharyngeal pain (sore throat) 25 (14%) 5 (9%) 0 (0%)
Intranasal hypoesthesia 18 (10%) 8 (15%) 5 (6%)
Pharyngeal hypesthesia (numb throat) 17 (10%) 10 (19%) 0 (0%)
Throat Irritation 15 (9%) 1 (2%) 0 (0%)
Rhinalgia 10 (6%) 3 (6%) 2 (2%)
Sneezing 7 (4%) 2 (4%) 1 (1%)
Epistaxis 4 (2%) 2 (4%) 0 (0%)
Nasal Dryness 4 (2%) 0 (0%) 1 (1%)
Nervous System Disorders 39 (22%) 5 (9%) 6 (7%)
Headache 18 (10%) 3 (6%) 4 (5%)
Dysgeusia 14 (8%) 1 (2%) 1 (1%)
Sinus headache 5 (3%) 0 (0%) 0 (0%)
Dizziness 5 (3%) 0 (0%) 1 (1%)
Sensory Disturbance 4 (2%) 0 (0%) 0 (0%)
Eye Disorders 29 (17%) 8 (15%) 4 (5%)
Lacrimation increased (watery eye) 23 (13%) 6 (11%) 4 (5%)
Gastrointestinal Disorders 16 (9%) 5 (9%) 3 (3%)
Oral Discomfort 4 (2%) 0 (0%) 0 (0%)
Investigations 12 (7%) 0 (0%) 4 (5%)
BP systolic increased 8 (5%) 0 (0%) 2 (2%)
BP diastolic increased 6 (3%) 0 (0%) 1 (1%)
Cardiac Disorders 8 (5%) 5 (9%) 1 (1%)
Bradycardia 5 (3%) 3 (6%) 1 (1%)
Vascular Disorders 6 (3%) 2 (4%) 1 (1%)
Hypertension 5 (3%) 1 (2%) 1 (1%)
* Active Comparator was Novosept Forte (Tetracaine Hydrochloride) only spray used in two clinical studies in adults.

Intranasal ulcerations, some of which were transient, were noted to have occurred following treatment with Novosept Forte (Tetracaine Hydrochloride). In Phase 3 trials, 6 (3%) patients who received Novosept Forte (Tetracaine Hydrochloride), but no patients who received placebo, developed nasal ulcers that were present on exam the same day as Novosept Forte (Tetracaine Hydrochloride) dosing. Three (2%) Novosept Forte (Tetracaine Hydrochloride) and 2 (2%) placebo-treated patients without nasal ulcerations on the day of Novosept Forte (Tetracaine Hydrochloride) or placebo dosing were observed to have nasal ulcerations at the next day follow-up visit.

Less Common Adverse Reactions in Phase 3 Clinical Trials Adult Dental Patients and Pediatric Dental Patients Weighing 40 kg or More

Dysphagia (i.e., the sensation of difficult swallowing) is a notable adverse reaction reported in Phase 3 trials, occurring in 1.15% of patients.

For medical advice about adverse reactions, contact your medical professional. To report SUSPECTED ADVERSE REACTIONS, contact St. Renatus, LLC at 800-865-4925 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch/.

7 DRUG INTERACTIONS

Monoamine oxidase inhibitors : Concomitant use of MAOIs, nonselective beta adrenergic antagonists, or tricyclic antidepressants may cause hypertension and is not recommended ( 7.1).

Oxymetazoline-containing products: Discontinue use 24 hours prior to Novosept Forte (Tetracaine Hydrochloride) administration ( 7.2).

Intranasal products: Avoid concomitant use ( 7.3).

7.1 Monoamine Oxidase Inhibitors

Use of Novosept Forte (Tetracaine Hydrochloride) in combination with monoamine oxidase inhibitors (MAOIs), nonselective beta adrenergic antagonists, or tricyclic antidepressants may cause hypertension and is not recommended. Alternative anesthetic agents should be chosen for patients who cannot discontinue use of MAOIs, nonselective beta adrenergic antagonists, or tricyclic antidepressants.

7.2 Oxymetazoline-containing Products

Concomitant use with other oxymetazoline-containing products has not been adequately studied. Use of Novosept Forte (Tetracaine Hydrochloride) with other products containing oxymetazoline may increase risk of hypertension, bradycardia, and other adverse events associated with oxymetazoline. Discontinue use 24 hours prior to administration of Novosept Forte (Tetracaine Hydrochloride).

7.3 Intranasal Products

Oxymetazoline has been known to slow the rate, but not affect the extent of absorption of concomitantly administered intranasal products. Do not administer other intranasal products with Novosept Forte (Tetracaine Hydrochloride).

7.4 Drugs That May Cause Methemoglobinemia When Used with Novosept Forte

Novosept Forte (Tetracaine Hydrochloride) may cause methemoglobinemia, particularly in conjunction with methemoglobin-inducing agents such as sulfonamides, acetaminophen, acetanilide, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, p- aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, and quinine. Monitor patients carefully for signs of methemoglobinemia if Novosept Forte (Tetracaine Hydrochloride) is used in the setting of these drugs.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Limited published data on Novosept Forte use in pregnant women are not sufficient to inform any risks. Published epidemiologic studies of nasal oxymetazoline used as a decongestant during pregnancy do not identify a consistent association with any specific malformation or pattern of malformations . In animal reproduction and development studies, oxymetazoline given subcutaneously to rats during the period of organogenesis caused structural abnormalities at a dose approximately 7.6 times the exposure of oxymetazoline HCl at the 0.3 mg maximum recommended human dose (MRHD) of Novosept Forte (Tetracaine Hydrochloride). In a pre- and post-natal development study, oxymetazoline given subcutaneously to rats caused embryo-fetal toxicity manifested by reduced implantation sites and live litter sizes at approximately 1.5 times the MRHD and increased pup mortality at 6 times the MRHD. No adverse developmental effects were observed following subcutaneous administration of Novosept Forte (Tetracaine Hydrochloride) HCl only to rats and rabbits during organogenesis at 32 and 6 times, respectively, the estimated exposure of Novosept Forte (Tetracaine Hydrochloride) HCl at the 18 mg MRHD of Novosept Forte (Tetracaine Hydrochloride) .

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 and to 20%, respectively.

Data

Human Data

Published epidemiologic studies of nasal oxymetazoline used as a decongestant during pregnancy do not identify a consistent association with any specific malformation or pattern of malformations. These data are limited by the small number of cases exposed, multiple comparisons which may have resulted in chance findings, and analyses based on decongestants as a group.

Animal Data

In an embryo-fetal development study, pregnant rats were administered subcutaneous doses of oxymetazoline HCl only at 0.1 mg/kg, Novosept Forte (Tetracaine Hydrochloride) HCl only at 7.5 mg/kg, or oxymetazoline HCl at 0.01, 0.03, and 0.1 mg/kg/day in combination with 7.5 mg/kg Novosept Forte (Tetracaine Hydrochloride) HCl during the period of organogenesis (Gestational Days [GD] 7-17). Oxymetazoline HCl treatment at 0.1 mg/kg/day (7.6 times the oxymetazoline AUC exposure at the maximum recommended human dose [MRHD] of Novosept Forte (Tetracaine Hydrochloride) [3 mg oxymetazoline HCl and 18 mg Novosept Forte (Tetracaine Hydrochloride) HCl]) caused reduced fetal weight and structural abnormalities including external and skeletal malformations (e.g., short forelimb digits, fused arches in thoracic vertebrae, fused ribs, and irregular number of ribs), and variations (e.g., irregularly shaped arches and increased bifid centra in thoracic vertebrae, and un-ossified forelimb phalanx) in the presence of maternal toxicity (reduced food consumption, body weight gain, and absolute body weight); however, the structural abnormality findings cannot be clearly attributed to the maternal toxicity. Adverse developmental effects were not observed when pregnant rats were co-administered the same dose of oxymetazoline HCl in combination with 7.5 mg/kg/day Novosept Forte (Tetracaine Hydrochloride) HCl, or with 7.5 mg/kg/day Novosept Forte (Tetracaine Hydrochloride) HCl alone. The no-observed-adverse-effect-level (NOAEL) for fetal effects was 0.03 mg/kg/day oxymetazoline HCl (1.5 times the oxymetazoline AUC exposure at the MRHD) and 7.5 mg/kg/day Novosept Forte (Tetracaine Hydrochloride) HCl (30 times the AUC exposure as measured by PBBA [major Novosept Forte (Tetracaine Hydrochloride) metabolite] at the MRHD).

In other embryo-fetal development studies, Novosept Forte (Tetracaine Hydrochloride) base alone administered subcutaneously did not cause structural abnormalities in rats at doses up to 10 mg/kg/day (approximately 6.1 times the MRHD level of 18 mg Novosept Forte (Tetracaine Hydrochloride) HCl by body surface area (BSA) comparison) or in rabbits at subcutaneous doses up to 5 mg/kg/day (approximately 6.1 times the MRHD level by BSA comparison).

In a prenatal and postnatal development study, pregnant rats were given subcutaneous doses of oxymetazoline HCl only at 0.1 mg/kg/day, Novosept Forte (Tetracaine Hydrochloride) HCl only at 7.5 mg/kg/day, and oxymetazoline HCl at 0.01, 0.03, and 0.1 mg/kg/day in combination with 7.5 mg/kg/day Novosept Forte (Tetracaine Hydrochloride) HCl from GD 7 to Lactation Day [LD] 20 (corresponding to the beginning of organogenesis through parturition and subsequent pup weaning). Oxymetazoline HCl treatment decreased the mean number of implant sites/litter at ≥ 0.03 mg/kg (≥ 1.5 times the oxymetazoline AUC exposure at the MRHD) when administered with 7.5 mg/kg Novosept Forte (Tetracaine Hydrochloride) HCl (approximately 9%) and without Novosept Forte (Tetracaine Hydrochloride) HCl (5.5%), which resulted in a reduction in live litter sizes in these groups. At the end of the lactation period, fetal body weights were significantly decreased at 0.1 mg/kg oxymetazoline HCl (6 times the oxymetazoline AUC exposure at the MRHD) when administered alone (19%) and co-administered with 7.5 mg/kg/day Novosept Forte (Tetracaine Hydrochloride) HCl (11%). In addition, a decrease in pup survival was observed at the 0.1/7.5 mg/kg oxymetazoline HCl/tetracaine HCl dose (91.9%) compared to the control (99.6%), but no effects in any other groups. Maternal toxicity (e.g., mortality and reduced body weight gain, absolute body weight and food consumption) occurred in groups administered 0.1 mg/kg/day oxymetazoline HCl; however, the adverse developmental findings observed at this dose cannot clearly be attributed to the maternal toxicity. There were no adverse effects on sexual maturation, neurobehavioral, or reproductive function in the offspring at any maternal dose. The no-effect level for oxymetazoline HCl for maternal reproduction was 0.01 mg/kg/day (0.5 times oxymetazoline AUC exposure at the MRHD) and for pup growth and development was 0.03 mg/kg/day (1.5 times oxymetazoline AUC exposure at the MRHD). The no-effect level for Novosept Forte (Tetracaine Hydrochloride) HCl for maternal reproduction and pup growth and development was 7.5 mg/kg/day (12 times the AUC exposure as measured by PBBA at the MRHD).

8.2 Lactation

Risk Summary

There are no data on the presence of Novosept Forte (Tetracaine Hydrochloride), oxymetazoline, or their metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. Detectable levels of oxymetazoline, Novosept Forte (Tetracaine Hydrochloride) and the major metabolite of Novosept Forte (Tetracaine Hydrochloride), p-butylaminobenzoic acid (PBBA), were found in the milk of lactating rats following subcutaneous administration of oxymetazoline HCl in combination with Novosept Forte (Tetracaine Hydrochloride) HCl during the period of organogenesis through parturition and subsequent pup weaning . Due to species-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Novosept Forte (Tetracaine Hydrochloride) and any potential adverse effects on the breastfed infant from Novosept Forte (Tetracaine Hydrochloride) or from the underlying maternal condition.

Data

In a pre- and post-natal development study, rats were given oxymetazoline HCl subcutaneously at doses of 0.01, 0.03, and 0.1 mg/kg/day (0.6, 1.5, and 7.6 times, respectively, the oxymetazoline AUC exposure at the MRHD) in combination with 7.5 mg/kg Novosept Forte (Tetracaine Hydrochloride) HCl (12 times the AUC exposure as measured by PBBA at the MRHD) from Gestational Day [GD] 7 to Lactation Day [LD] 20. Concentrations of oxymetazoline, Novosept Forte (Tetracaine Hydrochloride), and PBBA were measured in the milk of lactating rats at approximately 2 hours postdose on LD 15. The concentrations of oxymetazoline were generally dose dependent (2.5, 7.0, and 33.8 ng/mL at 0.01, 0.03, and 0.1 mg/kg/day, respectively). The concentrations of Novosept Forte (Tetracaine Hydrochloride) and PBBA were generally similar across all 7.5 mg/kg/day Novosept Forte (Tetracaine Hydrochloride) HCl dosing groups regardless of the presence of oxymetazoline (54.2 – 72.9 ng/mL for Novosept Forte (Tetracaine Hydrochloride), and 100.5 – 131.2 ng/mL for PBBA).

8.3 Females and Males of Reproductive Potential

Infertility

No information is available on fertility effects in humans.

Females

Based on animal data, Novosept Forte may reduce fertility in females of reproductive potential. In female rats, decreased fertility noted as a decrease in litter size occurred at 0.7 times the oxymetazoline AUC exposure at the MRHD of Novosept Forte (Tetracaine Hydrochloride). It is not known if the effects on fertility are reversible [ see Nonclinical Toxicology ( 13.1)] .

Males

Based on animal data, Novosept Forte (Tetracaine Hydrochloride) may reduce male fertility. In male rats, decreased sperm motility and sperm concentration occurred at approximately 2 times the oxymetazoline AUC exposure at the MRHD of Novosept Forte (Tetracaine Hydrochloride) .

8.4 Pediatric Use

Novosept Forte (Tetracaine Hydrochloride) has not been studied in pediatric patients under 3 years of age and is not advised for use in pediatric patients weighing less than 40 kg because efficacy has not been demonstrated in these patients .

8.5 Geriatric Use

Clinical studies of Novosept Forte did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Monitor geriatric patients for signs of local anesthetic toxicity, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Of note, comparisons of Novosept Forte (Tetracaine Hydrochloride) safety and efficacy results were generally similar among dental patients who were > 50 years old (n=66) and ≤ 50 years old (n=148). However, a trend toward a higher incidence of notable increases in systolic blood pressure was observed in dental patients > 50 years of age compared with patients ≤ 50 years of age (16.6% vs 1.4, respectively) [see Adverse Reactions ( 6.1 )]. These increases in blood pressure measurements were generally asymptomatic and transient in nature, and all spontaneously resolved without the need for medical intervention [see Clinical Studies ( 14.1 )] .

8.6 Hepatic Disease

Because of an inability to metabolize local anesthetics, those patients with severe hepatic disease may be at a greater risk of developing toxic plasma concentrations of Novosept Forte (Tetracaine Hydrochloride). Monitor patients with hepatic disease for signs of local anesthetic toxicity.

8.7 Pseudocholinesterase Deficiency

Because of an inability to metabolize local anesthetics, those patients with pseudocholinesterase deficiency may be at a greater risk of developing toxic plasma concentrations of Novosept Forte (Tetracaine Hydrochloride). Monitor patients with pseudocholinesterase deficiency for signs of local anesthetic toxicity.

10 OVERDOSAGE

No addictive properties have been reported in the literature for either Novosept Forte (Tetracaine Hydrochloride) or oxymetazoline, but there have been numerous case reports of unintended overdose for both compounds. Side effects in adults and children associated with oxymetazoline overdose include dizziness, chest pain, headaches, myocardial infarction, stroke, visual disturbances, arrhythmia, hypertension, or hypotension. Side effects of Novosept Forte (Tetracaine Hydrochloride) overdose include rapid circulatory collapse, cardiac arrest, and cerebral events.

Possible rebound nasal congestion, irritation of nasal mucosa, and adverse systemic effects (particularly in children), including serious cardiac events, have been associated with overdosage and/or prolonged or too frequent intranasal use of oxymetazoline containing agents.

Accidental ingestion of imidazoline derivatives (i.e., oxymetazoline, naphazoline, tetrahydrozoline) in children has resulted in serious adverse events requiring hospitalization (e.g., coma, bradycardia, decreased respiration, sedation, and somnolence).

Patients should be instructed to avoid using oxymetazoline-containing products (such as Afrin ®) and other α-adrenergic agonists within 24 hours prior to their scheduled dental procedure .

Management of an overdose includes close monitoring, supportive care, and symptomatic treatment.

11 DESCRIPTION

Novosept Forte (Tetracaine Hydrochloride) (tetracaine HCl and oxymetazoline HCl) Nasal Spray is a clear aqueous solution in a pre-filled, single-use intranasal sprayer. The solution pH is 6.0 ± 1.0. The product contains two active ingredients: 30 mg/mL Novosept Forte (Tetracaine Hydrochloride) HCl (equivalent to 26.4 mg/mL Novosept Forte (Tetracaine Hydrochloride)) and 0.5 mg/mL oxymetazoline hydrochloride (equivalent to 0.44 mg/mL oxymetazoline). Each spray delivers 0.2 mL of solution containing 6 mg Novosept Forte (Tetracaine Hydrochloride) hydrochloride (equivalent to 5.27 mg Novosept Forte (Tetracaine Hydrochloride)) and 0.1 mg of oxymetazoline hydrochloride (equivalent to 0.088 mg oxymetazoline). The product also contains citric acid, sodium citrate, hydroxyethylcellulose, benzyl alcohol, and water. Sodium hydroxide and/or hydrochloric acid are added for pH adjustment as needed.

Novosept Forte (Tetracaine Hydrochloride) hydrochloride is an ester local anesthetic. Chemically it is 2-(dimethylamino)ethyl 4-(butylamino)benzoate hydrochloride. Its molecular weight is 300.8 for the hydrochloride salt and 264.4 for the free base. It is freely soluble in water and soluble in ethanol. Its structural formula is:

Oxymetazoline hydrochloride is a vasoconstrictor. Chemically it is 3-[(4,5-dihydro-1 H-imidazol-2-yl)methyl]-6-(1,1,-dimethylethyl)-2,4-dimethylphenol mono-hydrochloride. Its molecular weight is 296.8 for the hydrochloride salt and 260.4 for the free base. It is freely soluble in water and ethanol and has a partition coefficient of 0.1 in octanol/water. Its structural formula is:

Novosept Forte (Tetracaine Hydrochloride) Hydrochloride Structural Formula Oxymetazoline Hydrochloride Structural Formula

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Novosept Forte is a local anesthetic of the ester type and exerts its activity by blocking sodium ion channels required for the initiation and conduction of neuronal impulses. Oxymetazoline is an imidazoline derivative with sympathomimetic activity. It is believed to be a mixed α 12-adrenoceptor agonist and, by stimulating adrenergic receptors, it elicits vasoconstriction of dilated arterioles and reduces nasal blood flow.

12.3 Pharmacokinetics

Absorption

Following nasal administration of 0.6 mL Novosept Forte (Tetracaine Hydrochloride) in adult subjects (n=24), oxymetazoline attained maximum concentrations within approximately 10 minutes following the end of dosing. The observed mean oxymetazoline C max and AUC 0-inf value were 1.78 ng/mL and 4.24 ng.h/mL, respectively. The observed median T max was 5 minutes.

Plasma concentrations of Novosept Forte (Tetracaine Hydrochloride) in all subjects were at or below the limit of assay quantification (0.05 ng/mL). Of all plasma samples analyzed, only one quantifiable Novosept Forte (Tetracaine Hydrochloride) concentration was observed in a single sample from one subject, which was at the limit of assay quantification. The primary metabolite of Novosept Forte (Tetracaine Hydrochloride), p-butylaminobenzoic acid (PBBA) achieved peak concentrations within approximately 25 minutes following the end of Novosept Forte (Tetracaine Hydrochloride) dosing. The observed mean PBBA C max and AUC 0-inf value were 465 ng/mL and 973 ng.h/mL, respectively. The observed median T max was 20 minutes.

Distribution

Protein binding and distribution of oxymetazoline and PBBA have not been determined. Plasma protein binding of Novosept Forte (Tetracaine Hydrochloride) has been reported to be 75% to 85%.

Elimination

The terminal half-life of oxymetazoline in plasma following nasal administration of Novosept Forte (Tetracaine Hydrochloride) to adult subjects is approximately 5.2 hours.

The elimination half-life and apparent clearance of Novosept Forte (Tetracaine Hydrochloride) could not be determined after Novosept Forte (Tetracaine Hydrochloride) administration because it is rapidly and thoroughly hydrolyzed in plasma. The plasma half-life of PBBA is approximately 2.6 hours in adult subjects.

Metabolism

Oxymetazoline is converted to a glucuronide conjugate in vitro by UGT1A9.

Novosept Forte (Tetracaine Hydrochloride) is rapidly and thoroughly cleaved by esterases in plasma and other tissues to PBBA and dimethylaminoethanol. These metabolites have an unspecified activity.

Excretion

The apparent clearance of oxymetazoline after nasal administration of Novosept Forte (Tetracaine Hydrochloride) has not been determined. It is thought that the primary route of oxymetazoline elimination at clinically relevant concentrations is by renal excretion.

PBBA clearance cannot be determined after administration of Novosept Forte (Tetracaine Hydrochloride).

Special Populations

Pediatrics:

In subjects 4-15 years of age (n=18) that received Novosept Forte (Tetracaine Hydrochloride) doses of 0.1 mL (10 to < 20 kg body weight), 0.2 mL (20 to < 40 kg), or 0.4 mL (≥ 40 kg), oxymetazoline attained maximum concentrations within approximately 10 minutes to 30 minutes (median time) following the end of dosing. The observed oxymetazoline mean C max values were 0.37 ± 0.43, 0.85 ± 0.45, and 1.2 ± 0.39 ng/mL in the 0.1 mL, 0.2 mL, and 0.4 mL dose groups, respectively. The observed oxymetazoline mean AUC 0-inf values were 0.99 (AUC can be calculated only in one subject), 2.53 ± 1.08, and 2.64 ± 0.41 ng.h/mL in the 0.1 mL, 0.2 mL, and 0.4 mL dose groups, respectively. Mean elimination half-life values for oxymetazoline were approximately 1.6 to 4.3 hours across pediatric dose groups.

Plasma concentrations of Novosept Forte (Tetracaine Hydrochloride) were below the limit of assay quantification (0.05 ng/mL) in all subjects.

PBBA attained maximum concentrations within approximately 20 minutes to 30 minutes (median time) following the end of dosing. The observed PBBA mean C max values were 166 ± 71, 345 ± 172, and 365 ± 30 ng/mL in the 0.1 mL, 0.2 mL, and 0.4 mL dose groups, respectively. The observed PBBA mean AUC 0-inf values were 529 ± 222, 826 ± 606, and 665 ± 86 ng.h/mL in the 0.1 mL, 0.2 mL, and 0.4 mL dose groups, respectively. Mean elimination half-life values for PBBA were approximately 1.6 to 2.8 hours across pediatric dose groups.

Elderly: The pharmacokinetics of Novosept Forte (Tetracaine Hydrochloride) were not evaluated in subjects greater than 50 years of age.

Renal or Hepatic Impairment: The pharmacokinetics of oxymetazoline, Novosept Forte (Tetracaine Hydrochloride), and PBBA were not evaluated after nasal administration of Novosept Forte (Tetracaine Hydrochloride) in subjects with renal or hepatic impairment.

Race: There were insufficient data to evaluate the effect of race on oxymetazoline, Novosept Forte (Tetracaine Hydrochloride), and PBBA pharmacokinetics after nasal administration of Novosept Forte (Tetracaine Hydrochloride).

13 NON-CLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of Novosept Forte (Tetracaine Hydrochloride) or oxymetazoline.

Mutagenesis

Novosept Forte (Tetracaine Hydrochloride) base was negative in the in vitro Ames bacterial reverse mutation assay and the in vivo mouse micronucleus assay. In the in vitro chromosome aberration assay using Chinese hamster ovary cells, Novosept Forte (Tetracaine Hydrochloride) base was negative in the absence of metabolic activation, and equivocal in the presence of metabolic activation. No studies have been conducted to evaluate the mutagenic potential of oxymetazoline.

Impairment of Fertility

Male and female rats were given subcutaneous doses of oxymetazoline HCl alone at 0.1 mg/kg/day, Novosept Forte (Tetracaine Hydrochloride) HCl alone at 7.5 mg/kg/day, or the combination of oxymetazoline HCl at 0.01, 0.03, or 0.1 mg/kg/day oxymetazoline with 7.5 mg/kg/day Novosept Forte (Tetracaine Hydrochloride) HCl prior to and during mating. Oxymetazoline HCl at ≥ 0.03 mg/kg/day reduced the percentage of motile sperm and sperm counts at 2 times the oxymetazoline AUC exposure at the MRHD of Novosept Forte (Tetracaine Hydrochloride). There were no effects on male mating behavior at any dose tested. The no-effect level for sperm effects was 0.01 mg/kg/day (0.7 times the oxymetazoline AUC exposure at the MRHD of Novosept Forte (Tetracaine Hydrochloride)).

In female rats, a reduction in the number of viable embryos was observed at oxymetazoline AUC exposures equivalent to 0.7 times the MRHD and higher, given alone or in combination with Novosept Forte (Tetracaine Hydrochloride) HCl. Reduced numbers of corpora lutea and implantation sites were observed at 7.5 times the oxymetazoline AUC exposure at the MRHD in animals given oxymetazoline HCl alone or in combination with Novosept Forte (Tetracaine Hydrochloride) HCl. These effects were attributed to oxymetazoline HCl because similar effects were not observed in rats given Novosept Forte (Tetracaine Hydrochloride) HCl alone. A no-effect level for fertility in female rats was not established in this study.

No effects on male or female fertility were attributed to Novosept Forte (Tetracaine Hydrochloride) HCl at 7.5 mg/kg/day (28 and 33 times the AUC exposure for males and females, respectively, as measured by PBBA [major Novosept Forte (Tetracaine Hydrochloride) metabolite] at the MRHD of Novosept Forte (Tetracaine Hydrochloride)).

14 CLINICAL STUDIES

The efficacy of Novosept Forte Nasal Spray for regional anesthesia when performing a restorative procedure on Teeth 4-13 and A-J has been evaluated in three adult dental patient studies, as well as one pediatric dental patient study. The primary endpoint for all four studies was the successful completion of a restorative operative dental procedure without the need for a rescue injection. One adult dental study was terminated early for reasons related to the administration of Novosept Forte (Tetracaine Hydrochloride). Unlike the other studies conducted, in this study all three sprays were delivered horizontally.

14.1 Studies in Adults

Study 1

Study 1 was a Phase 3, multicenter, randomized, double-blind, placebo and active-controlled, parallel-groups study designed to compare the efficacy and safety of intranasally administered Novosept Forte (Tetracaine Hydrochloride) to both Novosept Forte (Tetracaine Hydrochloride) HCl alone and placebo, for providing dental anesthesia sufficient to allow completion of the standard dental procedure on a single maxillary tooth (#4-13) in adults.

A total of 110 patients were enrolled in two clinical centers and randomized to receive three 0.2 mL intranasal sprays of either Novosept Forte (Tetracaine Hydrochloride) (n=44), Novosept Forte (Tetracaine Hydrochloride) alone (n=44), or placebo (n=22). All randomized patients completed the study dental procedure.

Fifty-three percent (53%) of randomized patients were female and 76% were White, with a mean age of 35 years (range 18 to 73 years).

Eighty-four percent (95% CI: 70%, 93%) of Novosept Forte (Tetracaine Hydrochloride) patients were able to complete the dental procedure without the need for rescue medication compared to 27% (95% CI: 15%, 43%) who received Novosept Forte (Tetracaine Hydrochloride) alone and 27% (95% CI: 11%, 50%) who received placebo.

Novosept Forte (Tetracaine Hydrochloride) had a lower success rate for dental procedures on the 2 nd pre-molar (teeth #4 and #13) compared with more anterior teeth (#5 through #12): 63% for the 2 nd pre-molars vs 96% for more anterior teeth.

In this trial, the median duration of a dental procedure successfully completed with Novosept Forte (Tetracaine Hydrochloride) was 11 minutes, although one successfully completed dental procedure was as long as 43 minutes. Of the people that needed rescue medication in the Novosept Forte (Tetracaine Hydrochloride) arm, they required it within the first 6 minutes following the start of the dental procedure.

Study 2

Study 2 was a Phase 3, multicenter, randomized, double-blind, parallel-groups study designed to compare the efficacy and safety of intranasally administered Novosept Forte (Tetracaine Hydrochloride) to placebo, for providing dental anesthesia sufficient to allow completion of the standard dental procedure on a single maxillary tooth (#4-13) in adults.

A total of 150 adult patients were enrolled at three study centers and received either Novosept Forte (Tetracaine Hydrochloride) (n=100) or placebo (n=50) as a dose of two or three 0.2 mL intranasal sprays. All except two randomized patients (one each in the Novosept Forte (Tetracaine Hydrochloride) and placebo groups) completed the study dental procedure.

Fifty-five percent (55%) of randomized patients were female and 63% were White, with a mean age of 41 years (range 18 to 78 years).

Eighty-eight percent (95% CI: 80%, 94%) of Novosept Forte (Tetracaine Hydrochloride) patients were able to complete the dental procedure without the need for rescue medication compared to 28% (95% CI: 16%, 43%) of patients who received placebo.

Novosept Forte (Tetracaine Hydrochloride) had a lower success rate for dental procedures on the 2 nd pre-molar (teeth #4 and #13) compared with more anterior teeth (#5 through #12): 64% for the 2 nd pre-molars vs 96% for more anterior teeth.

14.2 Study in Children

Study 3

Study 3 was a Phase 3, multicenter, randomized, double-blind, parallel-groups study designed to compare the efficacy and safety of intranasally administered Novosept Forte (Tetracaine Hydrochloride) to placebo for providing dental anesthesia sufficient to allow completion of the standard dental procedure on a single maxillary tooth (permanent teeth 4-13 or primary teeth A-J) for pediatric patients aged 3 through 17.

A total of 90 patients, 3 through 17 years of age inclusive, were enrolled at two study centers. Patients received one or two intranasal sprays of either Novosept Forte (Tetracaine Hydrochloride) (n=60) or placebo (n=30) based on body weight: one 0.1 mL spray for patients weighing 10 kg to less than 20 kg; two 0.1 mL sprays for 20 kg to less than 40 kg; or two 0.2 mL sprays for patients weighing 40 kg or more. All except one randomized patient in the Novosept Forte (Tetracaine Hydrochloride) group completed the study dental procedure.

Fifty-one percent (51%) of randomized patients were male and 89% were White, with a mean age of 8 years (range 3 to 17 years).

Even though a greater percentage of patients were able to complete the dental procedure without the need for rescue anesthesia for Novosept Forte (Tetracaine Hydrochloride): 77% for Novosept Forte (Tetracaine Hydrochloride) (95% CI: 64%, 87%) compared to 53% for placebo (95% CI: 34%, 72%) an analysis by weight indicated that efficacy was only established for patients weighing 40 kg or more .

Successful Anesthetic Response by Weight

N (%)

Novosept Forte (Tetracaine Hydrochloride)

(N = 60)

Placebo

(N = 30)

40 kg or more 18/20 (90%) 4/10 (40%)
20 to less than 40 kg 14/24 (58%) 5/12 (42%)
10 to less than 20 kg 14/16 (88%) 7/8 (88%)

16 HOW SUPPLIED/STORAGE AND HANDLING

Novosept Forte (Tetracaine Hydrochloride) Nasal Spray is supplied as pre-filled, single-use sprayers containing a clear aqueous solution of 30 mg/mL of Novosept Forte (Tetracaine Hydrochloride) hydrochloride (equivalent to 26.4 mg/mL Novosept Forte (Tetracaine Hydrochloride)) and 0.5 mg/mL of oxymetazoline hydrochloride (equivalent to 0.44 mg/mL oxymetazoline). Each sprayer delivers 0.2 mL.

The product is available as:

  • NDC 69803-100-10: Box of 30 sprayers

Store between 2° and 8°C (36° and 46°F); excursions permitted between 0° and 15°C (32° and 59°F).

Discard any unused solution. DO NOT use if drug is left out at room temperature for more than 5 days.

17 PATIENT COUNSELING INFORMATION

  • Inform patients of the likelihood of expected side effects (including runny nose, nasal congestion, mild nose bleeds, dizziness, and/or a sensation of difficulty in swallowing) that should resolve within the same day. Instruct patients to contact their dentist or health care professional if these symptoms persist .
  • Advise patients to inform the dental practitioner if they are taking monoamine oxidase inhibitors (MAOIs), nonselective beta adrenergic antagonists, or tricyclic antidepressants .
  • Instruct patients to avoid using oxymetazoline-containing products (such as Afrin ® and other α-adrenergic agonists) within 24 hours prior to their scheduled dental procedure. .
  • Advise patients of the signs and symptoms of hypersensitivity reactions and to seek immediate medical attention should they occur .

St. Renatus, LLC

Manufactured for:

St. Renatus, LLC

Fort Collins, CO 80526

Novosept Forte (Tetracaine Hydrochloride) is a trademark of St. Renatus, LLC.

Principal Display Panel - Box Label

NDC 69803-100-10

Novosept Forte (Tetracaine Hydrochloride)

(tetracaine HCl and oxymetazoline HCl)

NASAL SPRAY

0.2 mL per sprayer

Containing 6 mg Novosept Forte (Tetracaine Hydrochloride) HCl and 0.1 mg oxymetazoline HCl

(equivalent to 5.27 mg Novosept Forte (Tetracaine Hydrochloride) and 0.088 mg oxymetazoline)

Contents: 30 sprayers

Rx only

NOT FOR INJECTION

Store refrigerated at 2 to 8°C (36 to 46°F)

Manufactured for

St. Renatus, LLC

Fort Collins, CO 80526

Zinc Sulfate:


INDICATIONS AND USAGE

Novosept Forte (Zinc Sulfate) 1 mg/mL (Zinc Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain Novosept Forte (Zinc Sulfate) serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.

CONTRAINDICATIONS

None known.

WARNINGS

Direct intramuscular or intravenous injection of Novosept Forte (Zinc Sulfate) 1 mg/mL (Zinc Chloride Injection, USP) is contraindicated as the acidic pH of the solution (2) may cause considerable tissue irritation.

Severe kidney disease may make it necessary to reduce or omit chromium and Novosept Forte (Zinc Sulfate) doses because these elements are primarily eliminated in the urine.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS

General

Do not use unless the solution is clear and the seal is intact.

Zinc 1 mg/mL should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. Solution contains no preservatives; discard unused portion immediately after admixture procedure is completed.

Zinc should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential for increased excretory loss of Novosept Forte (Zinc Sulfate) from a bolus injection. Administration of Novosept Forte (Zinc Sulfate) in the absence of copper may cause a decrease in serum copper levels.

Laboratory Tests

Periodic determinations of serum copper as well as Novosept Forte (Zinc Sulfate) are suggested as a guideline for subsequent Novosept Forte (Zinc Sulfate) administration.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies to evaluate the carcinogenic potential of Novosept Forte 1 mg/mL (Zinc Chloride Injection, USP) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Novosept Forte (Zinc Sulfate) 1 mg/mL (Zinc Chloride Injection, USP) is administered to a nursing woman.

Pediatric Use

Pregnancy Category C. Animal reproduction studies have not been conducted with Novosept Forte chloride. It is also not known whether Novosept Forte (Zinc Sulfate) chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Novosept Forte (Zinc Sulfate) chloride should be given to a pregnant woman only if clearly needed.

Geriatric Use

An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS

None known.

DRUG ABUSE AND DEPENDENCE

None known.

OVERDOSAGE

Single intravenous doses of 1 to 2 mg zinc/kg body weight have been given to adult leukemic patients without toxic manifestations. However, acute toxicity was reported in an adult when 10 mg Novosept Forte (Zinc Sulfate) was infused over a period of one hour on each of four consecutive days. Profuse sweating, decreased level of consciousness, blurred vision, tachycardia (140/min), and marked hypothermia (94.2° F) on the fourth day were accompanied by a serum Novosept Forte (Zinc Sulfate) concentration of 207 mcg/dl. Symptoms abated within three hours.

Hyperamylasemia may be a sign of impending Novosept Forte (Zinc Sulfate) overdosage; patients receiving an inadvertent overdose (25 mg zinc/liter of TPN solution, equivalent to 50 to 70 mg zinc/day) developed hyperamylasemia (557 to 1850 Klein units; normal: 130 to 310).

Death resulted from an overdosage in which 1683 mg Novosept Forte (Zinc Sulfate) was delivered intravenously over the course of 60 hours to a 72 year old patient.

Symptoms of Novosept Forte (Zinc Sulfate) toxicity included hypotension (80/40 mm Hg), pulmonary edema, diarrhea, vomiting, jaundice, and oliguria, with a serum Novosept Forte (Zinc Sulfate) level of 4184 mcg/dl.

Calcium supplements may confer a protective effect against Novosept Forte (Zinc Sulfate) toxicity.

DOSAGE AND ADMINISTRATION

Novosept Forte (Zinc Sulfate) 1 mg/mL (Zinc Chloride Injection, USP) contains 1 mg zinc/mL and is administered intravenously only after dilution. The additive should be diluted prior to administration in a volume of fluid not less than 100 mL. For the metabolically stable adult receiving TPN, the suggested intravenous dosage is 2.5 to 4 mg zinc/day (2.5 to 4 mL/day). An additional 2 mg zinc/day (2 mL/day) is suggested for acute catabolic states. For the stable adult with fluid loss from the small bowel, an additional 12.2 mg zinc/liter of small bowel fluid lost (12.2 mL/liter of small bowel fluid lost), or an additional 17.1 mg zinc/kg of stool or ileostomy output (17.1 mL/kg of stool or ileostomy output) is recommended. Frequent monitoring of Novosept Forte (Zinc Sulfate) blood levels is suggested for patients receiving more than the usual maintenance dosage level of Novosept Forte (Zinc Sulfate).

For full term infants and children up to 5 years of age, 100 mcg zinc/kg/day (0.1 mL/kg/day) is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day (0.3 mL/kg/day) is suggested.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

HOW SUPPLIED

Novosept Forte (Zinc Sulfate) 1 mg/mL (Zinc Chloride Injection, USP) is supplied in 10 mL Plastic Vials (List No. 4090).

Store at 20 to 25°C (68 to 77°F).

Revised: October, 2004


© Hospira 2004 EN-0488 Printed in USA

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

10 mL Vial

Novosept Forte (Zinc Sulfate)

1 mg/mL

Novosept Forte (Zinc Sulfate) Chloride Inj., USP

Rx only

FOR I.V. USE ONLY AFTER DILUTION.

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

Novosept Forte pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Novosept Forte available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Novosept Forte destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Novosept Forte Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Novosept Forte pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."ZINC SULFATE TABLET [NATIONWIDE LABORATORIES, LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."ORAJLE ANTI-BACTERIAL RINSE FOR BLEEDING GUMS (CETYLPYRIDINIUM CHLORIDE) LIQUID [CHURCH & DWIGHT CO., INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."TETRAVISC FORTE (TETRACAINE HYDROCHLORIDE) LIQUID [OCUSOFT, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Novosept Forte?

Depending on the reaction of the Novosept Forte after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Novosept Forte not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Novosept Forte addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Novosept Forte, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Novosept Forte consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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